medical Class II Updated 2018-10-24

Siemens Healthcare Diagnostics, Inc recalls Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usa

Recalled Product

Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.

Hazard / Issue

A potential bias was identified with certain kits compared to the internal standards.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: SMN 10995532 Lot # Expiry UDI # 57837A66 2018-12-11 (01)00630414598598(10)57837A66(17)20181211 67443A66 2018-12-11 (01)00630414598598(10)67443A66(17)20181211
View official government recall

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